[Federal Register Volume 77, Number 214 (Monday, November 5, 2012)]
[Notices]
[Pages 66470-66471]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-26935]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

    Periodically, the Health Resources and Services Administration 
(HRSA) publishes abstracts of information collection requests under 
review by the Office of Management and Budget (OMB), in compliance with 
the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request 
a copy of the clearance requests submitted to OMB for review, email 
[email protected] or call the HRSA Reports Clearance Office on (301) 
443-1984.
    The following request has been submitted to the Office of 
Management and Budget for review under the Paperwork Reduction Act of 
1995:

Proposed Project: Sickle Cell Disease Treatment Demonstration Program--
Quality Improvement Data Collection for the Hemoglobinopathy Learning 
Collaborative (OMB No. 0915-xxxx)-[NEW]

    Background: In response to the growing need for resources devoted 
to sickle cell disease and other hemoglobinopathies, the United States 
Congress, under Section 712 of the American Jobs Creation Act of 2004 
(Pub. L. 108-357), authorized a demonstration program for the 
prevention and treatment of sickle cell disease (SCD) to be 
administered through the Bureau of Primary Health Care and the Maternal 
and Child Health Bureau (MCHB) of the Health Resources and Services 
Administration (HRSA) in the U.S. Department of Health and Human 
Services. The program is known as the Sickle Cell Disease Treatment 
Demonstration Program (SCDTDP). The SCDTDP is designed to improve 
access to services for individuals with sickle cell disease, improve 
and expand patient and provider education, and improve and expand the 
continuity and coordination of service delivery for individuals with 
sickle cell disease and sickle cell trait.
    In 2006, the MCHB Genetic Services Branch (GSB) awarded funding to 
a National Coordinating Center (NCC). The NCC was established to: (1) 
Collect, coordinate, monitor, and report on best practices and findings 
regarding the activities of the demonstration program; (2) identify a 
model protocol for eligible entities with respect to the prevention and 
treatment of Sickle Cell Disease; (3) identify educational materials 
regarding the prevention and treatment of Sickle Cell Disease; and, (4) 
prepare a final report on the efficacy of the demonstration program 
based on evaluation and quality improvement (QI) findings.
    To achieve the goals/objectives of the NCC, the National Initiative 
for Children's Healthcare Quality (NICHQ) and partners are facilitating 
the Hemoglobinopathy Learning Collaborative (HLC). The HLC includes 
grantee teams funded from the SCDTDP and the Sickle Cell Disease for 
Newborn Screening Program (SCDNBSP). The HLC uses a process known as 
the Model for Improvement, which is a widely used approach to QI in 
health care settings. The Model for Improvement utilizes a structured 
process that asks grantee teams, who hereafter will be referred to as 
improvement teams, to build on small tests of change in their health 
care setting, while providing monthly reporting on measurements. The 
proposed QI Data Collection and reporting system is an integral 
component of this model.
    Purpose: The purpose of this QI Data Collection strategy is to 
implement a system to monitor the progress of MCHB-funded activities in 
improving care and health outcomes for individuals living with sickle 
cell disease/trait and meeting the goals of the SCDTDP. Each 
improvement team will be asked to report on a core set of measures 
related to quality improvement for hemoglobinopathies. Through an 
evidence-based process, a bank of QI measures has been developed to 
assess health care utilization of the SCD population as well as several 
aspects of the system of care.
    The QI Data Collection strategy will provide an effective and 
efficient mechanism to do the following: (1) Assess the services 
provided by grantees under the SCDTDP and monitor and drive improvement 
on quality measures; (2) collect, coordinate, and distribute data, best 
practices, and findings from network sites; (3) refine a common model 
protocol regarding the prevention and treatment of sickle cell disease; 
(4) examine/address barriers that individuals and families living with 
sickle cell disease face when accessing quality health care and health 
education; (5) evaluate the grantees' performance in meeting the 
objectives of the SCDTDP; and, (6) provide HRSA/Congress information on 
the overall progress of the program.
    The proposed data collection and entry forms are as follows: (1) 
Participant Profile Form, (2) Acute Care Visit Form, and (3) Ambulatory 
Care Visit Form.
    Respondents: Grantees funded by HRSA under the SCDTDP will be the 
respondents for this data collection activity. Each month, SCDTDP teams 
will complete up to three data collection and entry forms for 20 
patients with SCD or sickle cell trait who were seen in their network 
that month. The Participant Profile form will collect demographic and 
basic health information. The Acute Care Visit and Ambulatory Care 
Visit forms will assess care in acute and ambulatory care settings, 
respectively.
    All information will be collected via medical chart review. Data 
will be entered directly into a secure web-based data collection tool, 
Research Electronic Data Capture (REDCap). The data entered into REDCap 
will be analyzed via a custom measurement generator that will calculate 
and export the QI

[[Page 66471]]

measures for viewing by improvement teams, the NCC, and HRSA.
    The annual estimate of burden is as follows:

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                                     Number of     Responses per       Total         Hours per     Total burden
           Instrument               respondents     respondent*      responses       response          hours
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Participant Profile Form........               9              12             108             5.0             540
Acute Care Visit Form...........               9              12             108            10.0            1080
Ambulatory Care Visit Form......               9              12             108            10.0            1080
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    Total.......................              27  ..............             324  ..............           2700
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* This burden table has been revised from the one published in the 60-day notice to reflect the accurate count
  of responses per respondent. The number 12 reflects the number of times a respondent will be approached for
  data collection annually, not the total number of data collection forms completed as was previously reported.

    Written comments and recommendations concerning the proposed 
information collection should be sent within 30 days of this notice to 
the desk officer for HRSA, either by email to [email protected] or by fax to (202) 395-6974. Please direct all 
correspondence to the ``attention of the desk officer for HRSA.''

    Dated: October 25, 2012.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2012-26935 Filed 11-2-12; 8:45 am]
BILLING CODE 4165-15-P